Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.
This recall has been terminated (originally issued October 23, 2007).
- Company
- Remington Medical Inc.
- Recall Initiated
- July 23, 2007
- Posted
- October 23, 2007
- Terminated
- April 6, 2009
- Recall Number
- Z-0058-2008
- Quantity
- 45,000 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility, inadequate -- Pathway may not be sterile as labeled.
Distribution
Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY.
Lot / Code Info
Lot # 20070423 (500-D), and Lot #20070420 (1000-D)
Root Cause
Process control
Action Taken
Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007. They were instructed to quarantine all affected product in inventory. If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter.
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